Fluid management devices and methods

ABSTRACT

A fluid management system for transferring fluid, the system including a connector component comprising a first end and an opposite second end, a first syringe with a distal end that is removably attachable to the first end of the connector component, and a second syringe with a distal end that is removably attachable to the second end of the connector component.

CROSS-REFERENCE TO RELATED APPLICATION

The application is a continuation application of U.S. Nonprovisionalapplication Ser. No. 13/060,185, filed May 24, 2011, and titled “FluidManagement Devices and Methods”, which claims benefit from InternationalApplication No. PCT/US2009/004788, which was filed on Aug. 21, 2009,which in turn claims priority to U.S. Provisional Application No.61/189,737, filed Aug. 22, 2008, which applications are incorporatedherein by reference in their entireties.

TECHNICAL FIELD

The present invention relates to the management of fluids in medical orlaboratory applications, and more particularly relates to devices,methods, and kits for transferring fluids in a controlled environment.

BACKGROUND

A surgical or invasive care suite is typically classified into separatetypes of areas, which include one or more “sterile” fields and one ormore “non-sterile” fields. The sterile and non-sterile fields aretypically included in the same physical space (e.g., a single operatingroom), with an imaginary vertical barrier being the only separationbetween these areas. In general, the sterile fields include areas wherethe highest level of sterility is required, which include the patient onwhich the procedure is being performed, the doctors, surgeons, and othermedical personnel participating in the surgical procedure, theinstruments and medical equipment required for the surgical procedure,and the entire area that immediately surrounds the sterile equipment andpersonnel. The sizes of these areas are preferably made to be as smallas possible due to the difficulty and costs associated with maintainingsterile environments. For example, a sterile field may comprise only atable holding sterile instruments, along with the space immediatelyabove that object. The non-sterile fields will typically comprise theremainder of the surgical suite that is not included in the sterilefield or fields, which can include all equipment and personnel that areneeded for the surgery but that need not be maintained in a completelysterile condition. However, it is typical to prepare or configureequipment, fluid, instruments, or other items in the non-sterile areasfor transfer into the sterile area to be used in the surgical procedure.Several methods and devices have been created for such a transfer ofequipment and materials so that the sterility plane is not broken;however, this can be difficult to accomplish, particularly when the itembeing transferred is a volume of fluid.

In current applications, a fluid may be prepared in a non-sterileenvironment and subsequently transferred to a sterile environment insuch a way that the fluid does not become contaminated. One method ofperforming such a fluid transfer is to first provide the fluid to asyringe by placing a sterile syringe tip into the fluid and drawing itinto the barrel of the syringe, such as by withdrawing a plunger of thesyringe relative to the syringe barrel. This fluid is then transferredto the sterile field by positioning the syringe so that it crosses theplane between the sterile and non-sterile fields, and then dischargingthe fluid into an open, sterile container (e.g., a sterile bowl orsimilar container) that is preferably immediately adjacent to theboundary between the fields. The fluid is then available for use in thesterile area of the surgical suite. Although this method can besatisfactory in some circumstances, there is a risk of fluids beingspilled during or after the process of transferring fluid to an opencontainer and there is also a risk that the non-sterile syringe willcome in contact with and thereby contaminate the sterile bowl or otheritems in the sterile field. In addition, it can often be difficult toremove all of the fluid from the open container in cases where fluid isbeing removed using an instrument such as syringe. This can therebyresult in fluid being left behind in the container, which will often bediscarded since it cannot be saved or reused. In some cases, such fluidloss can be acceptable, but in cases where the fluid is very expensiveand/or rare, for example, the loss of even a tiny amount of fluid can beunacceptable. Similarly, fluids containing cellular or proteintherapies, and the like, may become activated or otherwise caused toundergo unwanted changes. There is therefore a need for a fluidmanagement system that minimizes the risks and costs described abovewhile transferring fluid between a non-sterile environment and a sterileenvironment and/or between other types of environments.

SUMMARY

In one aspect of the invention, a device or system is provided fortransferring fluid from a non-sterile environment to a sterileenvironment without contacting and possibly contaminating the fluid. Thedevice or system comprises a syringe assembly that includes a firstsyringe, a second syringe, and a connector component or docking station.The connector component has a first end that is attachable to a firstsyringe in a sterile environment when the first syringe does not containfluid. The second syringe, which is in a non-sterile environment, isused to pull a quantity of fluid from a fluid supply location into itsinternal barrel and will be used for transferring this fluid to thefirst syringe. The first and second syringes are then brought togetherat the barrier between the sterile and non-sterile environments, with atleast a portion of the connector component (with the attached firstsyringe) being positioned in the non-sterile environment. The secondsyringe is then inserted into, or otherwise connected to, a second endof the connector component. The second syringe is then activated toeject the fluid that is within its internal barrel and transfer thisfluid into the first syringe through the internal area of the connectorcomponent.

The connector component of the device or system described above can beprovided with a gripping surface that can be grasped by the operator whois holding the second syringe (i.e., the syringe that is in thenon-sterile environment). In this way, after the fluid has beentransferred to the sterile syringe, the operator in the non-sterileenvironment can instruct the operator in the sterile environment todisconnect the first syringe (which is now holding the sterile fluid)from the connector component. This may be accomplished by simply pullingthe first syringe directly out of the connector component, or throughsome other method of disconnecting the components from each other. Inany case, the operator in the non-sterile environment will then beholding the second syringe with the attached connector component. Duringthis entire procedure, the operators in both the sterile and non-sterileenvironments do not contact the fluid and fluid pathway, although theconnector component can be handled at some point by operators in eitheror both environments.

In at least one aspect of the invention, the connector componentgenerally is configured as a tube having at least one port on each side.The tube includes at least a portion that can be grasped by an operatorand may include features or components that are molded, integrated, orotherwise attached to the outer surface of the tube. These features canprovide for a surface that makes it difficult for the component to slipfrom an operator's hand, particularly during and after the fluidtransfer operation.

In another aspect of the invention, one or both ends of the connectorcomponent include more than one port. These multiple ports can promote amixing and/or agitation/activation function for combining two or morefluids during the fluid transfer process. Additional fluid mixing can befacilitated by including ribs, nubs, or other extensions within thefluid pathway between the syringes. The number, size, positioning,orientation, etc. of these extensions can be specifically designed orselected to provide a desired amount of fluid mixing. The specificdesired mixing forces necessary for particularly components will be afactor in determining the characteristics for the mixing elements.

The fluid management systems of the invention may further be providedwith filters in one or more locations within the fluid pathway and ornanofibers that are designed to pull out or bind specific components(e.g., certain types or sizes of particles, cells, and/or proteins). Thefilters may comprise materials capable of acting as a separation medium,a filtration medium, or a growth matrix or surface, for example. Inother embodiments, the filters may comprise a network of one or more ofthe following: nanofibers; a nanofibrillar structure; glass, silicon, orplastic comprising an etched or micropatterned surface; glass, silicon,or plastic comprising macropores or nanopores; or a polymer scaffold. Incertain embodiments, the filters may comprise a filter membrane withmultiple longitudinally oriented stranded filter lumens.

The fluid management systems of the invention may also include luerports that are provided in different locations along one or more of thesyringes and/or connector components so that additional fluids orsubstances can be added to and/or mixed with a fluid during itstransfer. The system can further include one or more adaptors along thetube line for ease of handling. The fluid pathway tube may additionallyinclude synthetic graft, allograft, xenograft, and the like, which maybe provided within a syringe that includes these or different materialsto which fluid is added.

Although many of the aspects of the invention are described herein fortransfer of a fluid from a non-sterile environment to a sterileenvironment, it is understood that the same or similar principles,methods and devices can also be used for transferring fluid from asterile environment to a non-sterile environment, or for transfer offluids between other similar or different environments. In addition,several aspects of the invention described and shown herein are directedto fluid transfer between syringes; however, it is understood that thesame or similar principles, methods and devices can be used with otherdevices that can contain fluids such as bags, boxes, vials and the like,where fluid can be transferred between similar or different types offluid containers through a connector component that is attachable to anddetachable from both fluid containers.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIGS. 1-4 are side views of a fluid management system of the inventionand illustrating exemplary sequential steps in a fluid transfer process;

FIGS. 5 and 6 are perspective and side views, respectively, of a fluidmanagement system of the invention;

FIGS. 7 and 8 are perspective and side views, respectively, of a fluidmanagement system of the invention that includes a sterile fieldboundary indicator component;

FIGS. 9 and 10 are perspective and side views, respectively, of a fluidmanagement system of the invention that includes a sterile fieldboundary indicator component;

FIG. 11 is a perspective view of a portion of a fluid management systemof the invention that includes luer ports that provide a location forthe addition of components to the system during fluid transfer;

FIG. 12 is a perspective view of a portion of a fluid management systemof the invention that includes nanofibers along the fluid path, andincluding an enlarged cross-sectional view of a portion of the systemhaving nanofibers;

FIG. 13 is a perspective view of a portion of a fluid management systemof the invention that includes multiple mixing elements in the fluidpathway;

FIGS. 14 and 15 are perspective views of syringes having at least oneLuer port that can be used with the methods and systems of theinvention;

FIG. 16 is a perspective view of a syringe having a leer port and mixingelements that can be used with the methods and systems of the invention;

FIG. 17 is a perspective view of a syringe having a nozzle that can beused with the methods and systems of the invention;

FIG. 18 is a perspective view of a multiple syringe adaptor or connectorcomponent for use with a fluid management system of the invention;

FIG. 19 is a side view of a fluid management system including twosyringes on one side of a connector component and one syringe on anotherside of the connector component;

FIG. 20 is a side view of a fluid management system including aconnector component for attachment of three syringes on one side and onesyringe on another side;

FIG. 21 is a side view of another fluid management system of theinvention;

FIG. 22 is a side view of a fluid management system including aconnector component having a stabilizer bar;

FIGS. 23 and 24 are side views of fluid management systems including aLuer valve stick extending from a connector component;

FIGS. 25 and 26 are side views of a fluid management system of theinvention and illustrating sequential steps in a fluid transfer process;

FIGS. 27 and 28 are side and perspective views, respectively, of a fluidmanagement system of the invention;

FIGS. 29 and 30 are side views of a fluid management system of theinvention illustrating sequential steps in a fluid transfer process;

FIG. 31 is a side view of a fluid management system of FIGS. 29 and 30at a fluid transfer step where fluid has been transferred through aconnector component and tube to a fluid bag;

FIGS. 32 a-32 e are side views of a fluid management system of theinvention illustrating sequential steps in a fluid transfer process formtransferring fluid from a syringe to a bag;

FIGS. 33 a-33 d are side views of a fluid management system of theinvention illustrating sequential steps in a fluid transfer process fortransferring fluid from a syringe to a bag;

FIGS. 34 a-34 d are side views of a fluid management system of theinvention illustrating sequential steps in a fluid transfer process fortransferring fluid from a syringe to a vial or container;

FIGS. 35 a-35 d are side views of a fluid management system of theinvention illustrating sequential steps in a fluid transfer process fortransferring fluid from a syringe to a vial or container;

FIG. 36 is a side view of a fluid management system including aconnector component having locking mechanism;

FIGS. 37 a-37 c are enlarged perspective and side views of a portion ofthe fluid management system of FIG. 36 and including a lockingmechanism;

FIGS. 38 a-38 c are side views of fluid management systems of theinvention illustrating sequential steps in fluid transfer processesincluding a fluid-receiving container;

FIGS. 39 a-39 e are side views of fluid management systems of theinvention illustrating sequential steps in fluid transfer processesincluding a fluid-receiving container; and

FIGS. 40 a-40 d are side views of fluid management systems of theinvention illustrating sequential steps in fluid transfer processesincluding a fluid-receiving container.

DETAILED DESCRIPTION

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIGS.1-4, multiple exemplary sequential steps used for one exemplaryconfiguration of a fluid management system 10 and method of theinvention are illustrated. In general, the process step using system 10shown in FIG. 1 includes a first syringe 12 that is positioned entirelywithin a sterile environment (indicated by arrow 14 as the area to theleft of a schematic barrier line 22), a second syringe 16 that ispositioned entirely within a non-sterile environment (indicated by arrow18 as the area to the right of schematic barrier line 22), and aconnector component or docking station 20 attached to the distal end ofthe first syringe 12. The first syringe 12 includes a plunger 24 at itsproximal end and a tip element 26 at its distal end. The second syringe16 similarly includes a plunger 28 at its proximal end and a tip element30 at its distal end. The first and second syringes 12, 16 may beidentical to each other, or the syringes may be structured at leastsomewhat differently from each other.

The connector component 20 is a generally tubular structure thatincludes an outer surface that is cylindrical and an inner area that isconfigured for mating with the distal ends of the first and secondsyringes 12, 16. In particular, the connector component 20 includes afirst end 32 that can be engaged with the first syringe 12 and a secondend 34 that can be engaged with the second syringe 16. The inner area atthe first end 32 of the connector component 20 is an area or openingthat is designed to accept the distal end of the first syringe 12,preferably with a slideable and frictional fit between the components.Similarly, the inner area at the second end 34 of the connectorcomponent 20 is an area or opening designed to accept the distal end ofthe second syringe 16, preferably with a slideable and frictional fitbetween the components. The inner area of the connector component 20 isfurther provided with a channel 36 for fluid communication between theinner areas of its first and second ends 32, 34.

Referring again to the process step illustrated in FIG. 1, the firstsyringe 12 is inserted into the first end 32 of the connector component20 with its plunger 24 fully inserted into the barrel of the firstsyringe 12. That is, the first syringe 12 preferably does not containany fluid at this point, although it is possible that some substance,such as another fluid or material, has been provided within its barrel.This would require an expression port or would require that the plunger24 be retracted at least somewhat from the syringe barrel. In eithercase, both the first syringe 12 and the connector component 20 arepositioned within the sterile environment 14. At this stage, the secondsyringe 16 is provided with a volume of sterile fluid 38 within itsinternal barrel, which may have been transferred to this syringe 16 bypositioning the tip element 26 in fluid and withdrawing the plunger 28from the barrel until a desired amount of fluid was withdrawn. At thispoint, the second syringe is positioned entirely within the non-sterileenvironment 18. The barrier or boundary 22 between the sterile andnon-sterile environments 14, 18 is shown in the Figures as a verticalline, although it is understood that this boundary 22 can be a generallyvertical plane that extends from the edge of a sterile surface (e.g., adraped table or patient bed).

The first syringe 12 and its attached connector component 20 are thenbrought to the boundary 22 between the sterile environment 14 andnon-sterile environment 18 until at least a portion of the connectorcomponent 20 crosses through or over the boundary 22, as is illustratedin FIG. 2. The second syringe 16 is then inserted into the second end 34of the connector component 20 until it is nested within the inner areaof the connector component 20. At this point, the tip elements 26, 30 ofthe first and second syringes 12, 16, respectively, are shown as atleast partially extending into the channel 36 within the connectorcomponent 20. In order to avoid contamination of the fluid 38 and/orsyringes 12, 16 or other instruments, the tip elements 26, 30 aredesigned so that they do not contact each other within the connectorcomponent 20. Rather, the channel 36 can be at least slightly longerthan the combined lengths of the tip elements 26, 30 when they are fullyinserted into the channel 36, thereby providing a gap or space betweenthe tip elements 26, 30. Alternatively, the connector component 20 canhave an additional or alternative structure or device that prevents thetip elements 26, 30 from contacting each other.

When it is desired to transfer the fluid 38 from the second syringe 16to the first syringe 12, the plunger 28 of the second syringe 16 isactivated or pushed toward the distal end of the syringe (as illustratedby the arrow 40 in FIG. 3), thereby pushing the fluid 38 from itsinternal barrel and toward the first syringe 12. The sterile fluid 38will move toward the distal end of the second syringe 16, through thetip element 30 of the second syringe 16, and into the channel 36 of theconnector component 20. The plunger 24 of the first syringe 12 cansimultaneously be pulled outward from the barrel of the first syringe12, thereby drawing fluid 38 from the channel 36 of the connectorcomponent 20 into the barrel of the first syringe 12 through the tipelement 26. It is also contemplated that the pressure of the fluid 38being pushed through the channel 36 of the connector component 20 wouldbe sufficient to move the plunger 24 of the first syringe 12 proximallyrelative to its barrel. After the desired amount of sterile fluid 38 istransferred to the first syringe 12, the first syringe 12 can bedisconnected from the connector component 20, as is illustrated in FIG.4. As shown, the connector component 20 and attached second syringe 16will then remain in the non-sterile environment 18, while the firstsyringe 12, with sterile fluid 38 contained within its barrel, will beavailable for use within the sterile environment 14.

As discussed herein, a fluid may be any flowable material that isgenerally transferable via pressurization between or among chambers,including all components constituting or contained in the fluid. Onesuch exemplary fluid is blood, which contains multiple sub-componentssuch as cells and proteins. In this example, blood, and all of issub-components would be collectively referred to as a fluid.

FIGS. 5 and 6 illustrate a fluid management system 50 similar to thatdescribed above relative to FIGS. 1-4, where several of the componentsare again shown to be transparent for illustrative purposes. It is notedthat the actual components of the systems of the invention can beopaque, although it will be advantageous in some applications for thecomponents to be translucent or transparent in order provide at leastsome visibility of the fluid transfer process. It is further noted thatalthough many of the embodiments described herein specifically refer tofluid transfer from a non-sterile to a sterile environment, the sameconcepts, methods, and devices can be used to transfer fluid from asterile to a non-sterile environment, and/or to transfer fluid within asingle field (e.g., within a sterile field, non-sterile field, or thelike). Additionally, the concepts, methods, and devices of the inventioncan be used to transfer fluids between other types of environments orfields.

With regard to FIGS. 5 and 6, the fluid management system 50 includes afirst syringe 52 and a second syringe 54. The system 50 may bepositioned so that the first and second syringes 52, 54 are in sterileand non-sterile fields, respectively, with the second syringe 54initially containing the sterile fluid that is to be transferred to thefirst syringe 52. In this embodiment, FIG. 5 illustrates the firstsyringe 52 as having a first volume of the sterile fluid within itsbarrel, and FIG. 6 shows the first syringe 52 with a greater volume ofthe sterile fluid having been transferred to its barrel via a connectorcomponent 56. As with the embodiment of FIGS. 1-4, the first and secondsyringes 52, 54 are inserted into opposite ends of the connectorcomponent 56 until their respective tip elements 58, 60 are positionedwithin a channel 62 in the internal area of the connector component 56.

With respect to the embodiments of the invention, a channel providedwithin the internal area of the connector component can include walls orsurfaces that define the outer boundaries of the channel. These walls orsurfaces can further include a coating to modify the surface propertiesof the channel to improve fluid flow and/or the ability to handlecellular material. In the embodiment of FIG. 5, for example, a coating61 is placed on at least a portion of the interior walls of the channel62.

With respect to the embodiments of the invention, the central area ofthe channel or fluid transfer area within a connector component canfurther include at least one selection element or material. Thismaterial can be provided as only a small portion of the channel, or maycomprise the entire channel. The selection material may be provided witha number of capabilities such as a separation medium (e.g., affinitycolumns, packed bed matrices and beads, and/or nanofiber networks), afiltration medium, or a growth matrix or surface (e.g., nanofibernetworks). One or more ligands can also be attached to a filter element,which can be selected to bind one or more particular growth factors,differentiation factors, chemotactic factors and/or adhesion molecules.The ligands can be immobilized or coupled directly to a solid supportmaterial by formation of covalent chemical bonds between particularfunctional groups on the ligand and reactive groups on the support. Thefiltration element or material can comprise affinity or chromatographybeads or particles that can be, for example, glass, alginate, polymericor magnetic. These beads or particles are significantly smaller in sizethan affinity matrices or columns and are therefore particularly usefulfor microscale biological manipulations.

In cases where the selection material comprises a packed bed matrix orcolumn, the selection material can include a bed of granular material(e.g., sand, wood cellulose, or the like) that retains solid particlesthat pass through it while allowing fluids to flow freely. In caseswhere the selection material comprises a nanofiber network, theselection material can include one or more nanofibers, a nanofibrillarstructure, or glass, silicon, or plastic surfaces comprising an etchedor micropatterned surface, macropores, or nanopores. In yet anotheralternative, the selection element or material can comprise multiplelongitudinally oriented stranded filter lumens through which thefiltrate or retentate can move longitudinally.

The connector components of the devices and systems described hereinpreferably include at least a portion that can be grasped by an operatorand may include features or components that are molded, integrated, orotherwise attached to the outer surface of the tube, such as to provideanti-slip gripping surfaces. These features can provide a surface thatmakes it difficult for the component to slip from an operator's hand,particularly during and after the fluid transfer operation. Inparticular, the connector components of the devices or systems describedherein are preferably provided with a gripping surface that can begrasped by the operator who is holding the second syringe (i.e., thesyringe that is in the non-sterile environment) throughout the fluidtransfer process. In this way, after the fluid has been transferred tothe sterile syringe, the operator in the non-sterile environment caninstruct the operator in the sterile environment to disconnect the firstsyringe (which is now holding the sterile fluid) from the connectorcomponent. This may be accomplished by simply pulling the first syringedirectly out of the connector component if the connection is through africtional fit, or through some other method of disconnecting thecomponents from each other if the components were initially connected insome other way. In any case, the operator in the non-sterile environmentwill then be holding the second syringe within the attached connectorcomponent. During this entire procedure, the operators in both thesterile and non-sterile environments do not contact the fluid pathway orany of the fluids contained therein.

FIGS. 7 and 8 illustrate another aspect of a fluid management system 70of the invention, which also generally includes first and secondsyringes 72, 74 that are attachable to a central connector component 76.The connector component 76 of this embodiment is further provided with asterile field boundary indicator 78, which in this case is illustratedas a slotted disk that extends from the outer surface of the connectorcomponent 76. This boundary indicator 78 provides an operator withguidance on where to locate the system 70 during the fluid transferprocess in order to keep the sterile and non-sterile components withintheir respective environments. Thus, the illustrated shape and size ofthe boundary indicator can be somewhat or considerably different fromthat shown, where any configuration of the indicator 78 that providesthis function to the operators is contemplated by the invention. Thisboundary indicator can optionally have one or more visual markers on oneor both sides to designate which direction the connector componentshould be oriented, such as color-coding, indicia, or the like. In oneembodiment, the connector component includes a ring at one of its endsthat also includes a visual marker that corresponds to the visual markeron the sterile field boundary indicator. For example, one side of theboundary indicator can be yellow and a ring or other portion of theconnector component and/or syringe can also be yellow to provide theoperators with visual assurance of the proper placement of thecomponents of the system.

Another embodiment of a fluid management system 80 of the inventionhaving a sterile field boundary indicator 82 is illustrated in FIGS. 9and 10. This boundary indicator is provided as a curved shield thatextends from an outer surface of a connector component 84 of the system.The shield 82 further provides protection for the operator's hand bypreventing inadvertent contamination that could be caused by contactbetween the hands of the operators or other items in the sterile andnon-sterile environments. This boundary also provides operators withprotection against needle sticks and residual bio fluid or materialleakage. Again, this embodiment may be provided with color-coding orother visual indicia on at least a portion of the connector component 84(e.g., the boundary indicator) to provide guidance to the operators forproper orientation of the system. One or both syringes 86, 88 of thissystem can be provided with a portion that is color-coded to coordinatewith color-coding on the connector component 84 in order to assist theoperators in achieving the proper orientation of the components withinthe system.

FIG. 11 illustrates a portion of a fluid management system 90 thatincludes a first syringe 92 and a second syringe 94, which are eachattached to a central connector component 96. The connector component 96comprises at least one luer port 98 that allows an operator to addmaterials, such as fluids, to the system 90. Such a transfer ofmaterials to the system 90 can be performed before, during, and/or afterthe fluid transfer process is completed. As shown, the luer port 98 isin communication with a channel 97 within the connector component 96 ofthe system, which is the area through which the fluid will flow as it ismoved into a sterile syringe. Thus, one or more luer ports 98 canprovide a mixing function for combining two or more fluids during thefluid transfer process. Each luer port 98 can optionally include ametering function to provide for the addition of components at a certainratio or concentration to achieve a final product having certainproperties. Luer port 98 can additionally be used to pressurize thechannel 97.

The fluid management systems of the invention may further be providedwith filters in one or more locations along the fluid pathway and/ornanofibers that are designed to remove specific components from thefluid (e.g., certain types or sizes of particles). FIG. 12 illustratesan enlarged view of a portion of one embodiment of a fluid managementsystem 100 that includes such nanofibers located along the fluid path,which are designed to pull components out of the fluid during the fluidtransfer process. In particular, FIG. 12 also shows a cross-sectionalview of a central channel 102 that includes nanofibers. This and othersystems of the invention can include filtration features that aredescribed above relative to FIGS. 5 and 6; however, in one particularexemplary embodiment, the fluid system includes a nanofiber networkcomprising a fiber diameter of about 30 nm to about 1200 nm, averageinterfiber spacing of about 100 nm to about 600 nm, and solidity ofabout 70 percent or less. The nanofibers can be fabricated from avariety of polymers or polymer systems, such as a polyamide orpolyester, for example.

In order to mix or otherwise agitate the fluid during the fluid transferprocess, ribs, nubs, or other extensions can be provided within a fluidpathway between the syringes of a fluid management system of theinvention. One example of such a configuration is illustrated in a fluidmanagement system 110 of FIG. 13, which includes a number of angledfingers or extensions 112 positioned generally in a channel 114 of aconnector component 116 to promote mixing of the fluid or fluids as theymove from one syringe to the other through the channel 114. The number,size, positioning, orientation, etc. of these extensions 112 can bedifferent from that shown, and the extensions of any particular systemcan be specifically designed or selected to promote a desired amount offluid mixing. The specific desired mixing forces necessary forparticular components or materials will be a factor in determining thecharacteristics chosen or designed for the mixing elements.

Additional embodiments of syringes 120, 130, 140, and 150 that can beused with the fluid management systems of the invention are illustratedin FIGS. 14 through 17, respectively. These syringe embodiments eachinclude a plunger that is insertable into a barrel at its proximal end.The syringe 150 of FIG. 17 includes a tapered tip portion 152, and thesyringe 120 of FIG. 14 also includes a tapered tip portion 122, whichincludes a luer port 124 that provides a location to introduce fluidsduring the fluid transfer process. The tapered tip portions of theseembodiments can cause the fluid to become activated or agitated due tothe increased pressure placed on the fluid as is moved through thedecreasing diameter of the tip toward its open end. In some cases, thisactivation of the fluid can eliminate a processing step that would needto otherwise be performed separately.

FIG. 15 illustrates a syringe 130 that includes three separate luerports 132 to allow for the addition of three separate components, ifdesired. FIG. 16 illustrates another syringe 140 that is similar to thatof FIG. 14, although this syringe 140 also includes mixing nubs orextensions 142 within a tapered tip portion 144, along with at least oneluer port 146 positioned along the tapered tip portion 144 of thesyringe 140. Any of the fluid management systems of the invention mayadditionally or alternatively include luer ports that are provided indifferent and/or additional locations and/or quantities along one ormore of the syringes and/or the connector component so that additionalfluids or substances can be added to the sterile fluid during itstransfer.

A syringe 160 that can introduce multiple fluids into a fluid managementsystem in accordance with the invention is illustrated in FIG. 18. Thesyringe 160 is provided with two barrels 162, 164, and two fluids areshown as being provided in the barrels 162, 164. However, it isunderstood that additional barrels can be provided if it is desired tosupply more than two fluids. hi this embodiment, the syringe 160includes two barrels 162, 164, a dual plunger 166 at its proximal end,and a mixing insert 168 at its distal end 165. To dispense fluid fromthe distal end 165 of the syringe 160, the plunger 166 is pushed towardthe distal end 165, thereby forcing fluid from the barrels 162, 164 andinto the mixing insert 168. After the fluid passes through the mixinginsert 168, it can be dispensed from the syringe 160 through a syringetip 167 and into a connector component, as described above relative toother embodiments of the invention. It is contemplated that additionalmixing of the fluids can be caused or promoted within the connectorcomponent, such as when the connector component is provided with mixingextensions or fingers within the fluid path, as described above relativeto FIG. 13, for example.

FIGS. 19 and 20 illustrate additional embodiments fluid managementsystems 170, 180, respectively, of the invention. Fluid managementsystem 170 includes a dual syringe device 172 having two barrels, whichsupplies materials or fluids to a single receiver syringe 174 through aconnector component 176. The connector component 176 includes multipleinternal channels 178 that merge together to provide a single fluidsupply to the receiver syringe 174. Similarly, fluid management system180 includes a triple syringe device 182, which supplies materials orfluids to a single receiver syringe 184 through a connector component186. The connector component 186 includes multiple internal channels 188that merge together to provide a single fluid supply to the receiversyringe 184. However, it is understood that a connector component inaccordance with the invention can have any number of ports or openingsinto which one or more syringes can be inserted for transfer of fluids.Each of the multiple syringe devices, such as devices 172, 182, can haveplungers that are independently moveable within their respective barrelsrelative to other plungers, or the plungers of all of the syringes in amultiple barrel syringe can be linked or connected to each other so thatthey all move together.

FIG. 21 illustrates a fluid management system 190 that includes aconnector component 192 having a relatively long internal channel 194through which fluid can travel between the syringes 196, 198. Such anextended channel length can provide additional locations to placefilters and/or other materials through which the fluid can pass duringfluid transfer.

FIG. 22 illustrates a fluid management system 200 having a connectorcomponent 202 with a handle or extending portion 204. The system 200further includes a first syringe 206 attached to one end of theconnector component 202 and a second syringe 208 attached to theopposite end of the connector component 202. As with other embodimentsof the invention described herein, fluid can be moved from one of thesyringes to the other through the connector component 202. The extendingportion 204 of the connector component 202 can provide an operator withadditional stability for grasping the device during a fluid transferprocess, for example. The extending portion 204 can have a differentconfiguration than shown (e.g., it can be differently sized or shaped,can have additional gripping surfaces, and the like). It is furthercontemplated that the connector component 202 can comprise an extendingportion on both sides of its boundary indicator 212.

FIGS. 23 and 24 are fluid management systems 230, 240 of the invention,respectively. The system 230 includes a connector component 232 with anextending portion 234 extending from its outer curved surface. Theextending portion 234 includes a rotatable valve 235 that can be used tocontrol the inflow of additional fluids to the connector component 232and/or to a channel 236 within the connector component 232. Similarly,the system 240 includes a connector component 242 with an extendingportion 244 extending from its outer curved surface. The extendingportion 244 is considerably shorter than the extending portion 234 ofsystem 230, but also includes a rotatable valve 245 that can be used tocontrol the inflow of additional fluids to the connector component 242and/or to a channel 246 within the connector component 242. That is,these extending portions 234, 244 can optionally be in fluidcommunication with the fluid transfer channel of their respectiveconnector components.

FIGS. 25 and 26 illustrate sequential steps for using a fluid managementsystem 250 of the invention in a fluid management process. Fluidmanagement system 250 includes a fluid container 252 to which aconnector component 254 can be permanently or removably attached. Thesystem 250 further includes a syringe 256, which is shown in FIG. 25 ascontaining a volume of fluid 258 within its internal barrel. It is notedthat the fluid container 252 includes an inner fluid reservoir 260 thatdoes not contain any fluid in FIG. 25, but that is designed to acceptfluid from a syringe. The connector component 254 is configured toaccept the syringe 256 on one side and attach to the fluid container 252on another side. The inner fluid reservoir 260 is shown in these Figuresas being substantially smaller than the overall size of the fluidcontainer 252; however, the inner reservoir 260 may instead be smalleror larger than shown. All or some of the fluid 258 can be transferred tothe fluid reservoir 260 of the fluid container 252 by attaching thesyringe 256 to the connector component 254 and pushing a barrel 262 ofthe syringe 256 toward its distal tip, thereby forcing fluid into thereservoir 260, as illustrated in FIG. 26. When a desired volume of fluid258 has been transferred to the reservoir 260, the syringe 256 can bedetached from the connector component 254. The connector component 254can also be detached from the fluid container 252, if desired.

FIGS. 27 and 28 illustrate another embodiment of a fluid managementsystem 270 that is similar to system 250 described relative to FIGS. 25and 26. In this embodiment, a fluid container 272 is provided thatgenerally comprises a shell with an internal area that can accept fluidtransferred from a syringe. This fluid container 272 thus has adifferent configuration than the fluid container 252 described above,which may be desirable for certain applications, such as reconstituting,impregnating, infusing, or bathing a material, such as an allograft.

FIGS. 29-31 illustrate another embodiment of a fluid management system280 of the invention, which includes a connector component 282 having anopening or receiver port 284 at one end into which a syringe 286 can beinserted, and a tube 288 extending from an opposite end 290 that isattachable to a bag 292 or other fluid-receiving container. The bag 292can be flexible or rigid. The tube 288 can be relatively long or short,depending on the desired fluid transfer process. The tube 288 can beremovable from the bag 292, if desired, such as through the use of afitting that allows the bag 292 to be removed from the tube 288 withoutallowing fluid to leak from the bag. Further, the tube 288 can bepermanently or removeably attached to the connector component.

With continued reference to the sequential steps of FIGS. 29-31, FIG. 29illustrates the connector component 282 attached to the bag 292 via thetube 288, and the separate syringe 286, which includes fluid 294 withinits barrel. The syringe 286 can then be attached to the connectorcomponent 282, as illustrated in FIG. 30, and fluid can begin to betransferred from the syringe 286 to the bag 292 by pressing a plunger294 of the syringe 286 toward its distal end to move fluid in adirection indicated by arrow 296. After a desired amount of fluid istransferred from the syringe 286, it can be disconnected from theconnector component 282, as is illustrated in FIG. 31. It is noted thatFIG. 31 also illustrates the bag 292 with a volume of fluid 294contained therein.

FIGS. 32 a-32 e illustrate sequential fluid transfer steps using anotherembodiment of a fluid management system 300 of the invention, whichincludes a syringe 302, a connector component 304, a tube 306, and a bagor reservoir 308. These components can all be removably attachable toeach other, or some of the components may be permanently orsemi-permanently connected to each other. For example, the tube 306 canbe permanently attached to the connector component 304, as isillustrated in FIG. 32 e. FIG. 32 a shows the syringe 302 containing avolume of fluid, FIG. 32 b shows the syringe 302 attached to theconnector component 304 prior to fluid transfer, and FIG. 32 c shows thesyringe 302 as having no fluid within its barrel and with the fluidbeing contained within the bag 308. FIGS. 32 d and 32 e illustrate thecomponents of the system 300 detached from each other after the fluidtransfer process is completed. It is noted that the bag 308 can includea self-closing seal 309 or other sealing configuration that preventsfluid from leaking from the bag 308 after it has been transferred to itfrom the syringe 302.

FIGS. 33 a-33 e illustrate sequential fluid transfer steps using anotherembodiment of a fluid management system 310 of the invention. System 310includes a syringe 312, a connector component 314, a tube 316, and a bagor reservoir 318. This system is similar to that described aboverelative to FIGS. 32 a-32 e; however, in this embodiment, the tube 316remains attached to the connector component 314, which in turn remainsattached to the syringe 312 after these components are detached from thebag or reservoir 318.

FIGS. 34 a-34 d illustrate sequential steps in fluid transfer processesusing another embodiment of a fluid management system 320 of theinvention. System 320 includes a vial or container 322, such as acontainer commercially available under the tradename “Vacutainer”, towhich fluid is transferred through a connector component 324 from asyringe 326. FIG. 34 a illustrates the syringe 326 containing fluid andattached to the connector component 324 prior to the vial or container322 being attached to the system. Once the container 322 is attached tothe connector component 324 and fluid has been transferred from thesyringe 326 into the container 322, as illustrated in FIG. 34 b, thecontainer 322 can be disconnected from the system, as illustrated inFIG. 34 d. As shown in the Figures, once the fluid has been transferredfrom the syringe 326, the entire assembly can be moved from one fieldinto the other, if desired.

FIGS. 35 a-35 d illustrate a system 330 that is similar to the system320; however, a vial or container 332 is attached to a connectorcomponent 334 prior to attachment of the connector component 334 to asyringe 336 containing fluid, as is illustrated in FIG. 35 a. Again,once the syringe 336 is attached to the connector component 334 andfluid has been transferred from the syringe 336 into the container 332,as illustrated in FIG. 35 c, the container 332 can be disconnected fromthe system, as is illustrated in FIG. 35 d.

FIG. 36 and FIGS. 37 a-37 c are multiple views of a fluid managementsystem 350 having a mechanism 356 on a connector component 352 thatprovides for positive engagement between a first syringe 354 and oneside of the connector component 352. The mechanism 356 includes at leastone moveable tab 358 for engagement with a syringe. Mechanism 356 may beconfigured so that the syringe 354 is not detachable from the connectorcomponent 352 once the syringe 354 is engaged with the mechanism (i.e.,the mechanism acts as a lock between the components). Alternatively, thesyringe can be removeable from the connector component after it has beenattached thereto. The mechanism may further be configured so it engageswith only specific types of syringes, thereby preventing unintentionalattachment of certain syringes to a designated side of the connectorcomponent, for example. Features of this mechanism can be utilized withvarious embodiments of the present invention where it is determined thatparticular locking or engagement features are desirable.

FIGS. 38 a-38 c, FIGS. 39 a-39 e, and FIGS. 40 a-40 d illustratesequential steps of fluid transfer processes using fluid managementsystems 360, 370, and 380, respectively. Each of these fluid managementsystems includes a fluid-receiving container. As shown, the variouscomponents of each of these systems can be attached and/or detached fromeach other before and/or after the transfer of fluid from a syringe to afluid-receiving container.

As was briefly described above, the descriptions herein of fluid beingtransferred from a syringe to particular containers or syringes througha connector component can also be performed in an opposite direction inthe embodiments of the invention. That is, fluid can also be transferredfrom a bag, box, or fluid-receiving container into a syringe, such as byretracting a plunger from a syringe to withdraw fluid from such a vesselor container.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

1. A fluid management system for transferring fluid, the systemcomprising: a connector component comprising: an outer surface extendingfrom a first end to a second end; a first end portion comprising a firstopening with a first cross sectional area that extends from the firstend toward a central portion of the connector component; a second endportion comprising a second opening with a second cross sectional areathat extends from the second end toward the central portion of theconnector component; a channel fluidly connecting the first opening andthe second opening, wherein the channel is located in the centralportion of the connector component and comprises a third cross sectionalarea that is smaller than the first and second cross sectional areas;and at least one port extending from the outer surface of the connectorcomponent into the channel for fluid communication with an inner area ofthe channel; a first syringe comprising a distal end that is removablyattachable with the first end portion of the connector component; and asecond syringe comprising a distal end that is removably attachable withthe end portion of the connector component.
 2. The fluid managementsystem of claim 1, wherein the at least one port comprises multipleports spaced from each other along a length of the channel.
 3. The fluidmanagement system of claim 1, wherein at least one port comprises ametering component.
 4. The fluid management system of claim 1, whereinthe channel is pressurizable by the at least one port.
 5. The fluidmanagement system of claim 1, wherein the at least one port comprises aluer port.
 6. The fluid management system of claim 1, wherein theconnector component comprises a tubular member.
 7. The fluid managementsystem of claim 1, wherein the first syringe is slideably engageablewithin the first end portion of the connector component and the secondsyringe is slideably engageable within the second end portion of theconnector component.
 8. The fluid management system of claim 1, whereinthe connector component further comprises a boundary indicator extendingoutwardly from at least a portion of the outer surface of the connectorcomponent between its first and second ends.
 9. The fluid managementsystem of claim 8, wherein the boundary indicator extends from the outersurface of the connector component around the entire perimeter of theconnector component.
 10. The fluid management system of claim 1, whereinthe fluid comprises at least one of a solution, a suspension, a cellularfluid, and a protein solution.
 11. A syringe comprising: a barrel havinga first outer surface, a proximal end, a distal end, and an inneropening extending from the proximal end to the distal end; an axiallyslideable plunger positionable within the inner opening of the barrel; atip extending distally from a distal end of the barrel, the tipcomprising a length, an inner opening, and an outer surface; and atleast one port extending from the outer surface of the tip into itsinner opening.
 12. The syringe of claim 11, further comprising multipleports spaced from each other along the length of the tip.
 13. Thesyringe of claim 11, wherein the tip further comprises at least onemixing component within its inner opening.
 14. The syringe of claim 11,wherein the tip comprises a tapered profile.
 15. The syringe of claim11, wherein the at least one port comprises at least one luer port. 16.The syringe of claim 11, wherein the at least one mixing componentcomprises extensions that extend from an inner surface of the tip towarda central longitudinal axis of the tip.
 17. The syringe of claim 11, incombination with a connector component comprising: an outer surfaceextending from a first end to a second end; a first end portioncomprising a first opening with a first cross sectional area thatextends from the first end toward a central portion of the connectorcomponent, wherein the distal tip and at least a portion of the barrelare slidably engageable within the first opening; a second end portioncomprising a second opening with a second cross sectional area thatextends from the second end toward the central portion of the connectorcomponent; and a channel fluidly connecting the first opening and thesecond opening, wherein the channel is located in the central portion ofthe connector component and comprises a third cross sectional area thatis smaller than the first and second cross sectional areas.
 18. Thecombination of claim 17, wherein the connector component furthercomprises at least one channel extending from the outer surface of theconnector component into the channel for fluid communication with aninner area of the channel;
 19. The combination of claim 17, further incombination with a second syringe comprising: a second barrel having asecond outer surface, a second proximal end, a second distal end, and asecond inner opening extending from the second proximal end to thesecond distal end; a second axially slideable plunger positionablewithin the second inner opening of the second barrel; a second tipextending from a second distal end of the barrel, the second tipcomprising a length, an inner opening, and an outer surface; and atleast one port extending from the outer surface of the second tip intoits inner opening.